Urine Toxicology With Pharmacogenomic Interpretation Assay: UTOPIA

NCT ID: NCT02096172

Last Updated: 2014-09-23

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-03-31

Brief Summary

The objective of this study is to evaluate the impact of pharmacogenomic aspects of drug metabolism on the measurement of drug and drug metabolites on urine drug testing (UDT).

Conditions

Urine Toxicology

Study Design

• Observational Model Type: COHORT

Eligibility Criteria

Inclusion Criteria

• Able to provide written informed consent
• Pharmacogenomic testing within the last 60 days
• Planned UDT

Exclusion Criteria

• Subject has chronic renal dysfunction, Chronic Kidney Disease Stage 4 or 5
• Subject has a history of abnormal hepatic function within the last 2 years (INR >1.2 not attributable to anticoagulant medications, AST or ALT >1.5x normal, or suspected cirrhosis)
• Subject has a history of malabsorption (short gut syndrome);
• Subject has a history of any gastric or small bowel surgery;
• Subject is currently hospitalized;
• Subject is currently receiving intravenous medication.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Syntactx

NETWORK

Sponsor Role: collaborator

Renaissance RX

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2013-002

Identifier Type: -

Identifier Source: org_study_id